MAUDE Adverse Event Report: ST. JUDE MEDICAL / ABBOTT MEDICAL DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number 1458Q

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

It was reported that this lead was explanted due to infection.The lead is no longer in service.No additional adverse patient effects were reported.Disclaimer statement: this report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): ST. JUDE MEDICAL / ABBOTT MEDICAL
• MDR Report Key: 18994574
• MDR Text Key: 338954266
• Report Number: MW5153335
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1458Q
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1